A Multicenter, Phase I Dose-Escalating Study of Docetaxel, Cisplatin and S-1 for Advanced Gastric Cancer (KDOG0601)

Objective: This dose-escalation study of a combination of docetaxel, cisplatin and S-1 investigated the dose-limiting toxicity (DLT), maximum-tolerated dose (MTD), recommended dose (RD) and antitumor activity in advanced gastric cancer. Patients and Methods: Patients received docetaxel (40 mg/m²), cisplatin (DIV on day 1) and S-1 (40 mg/m² p.o., twice daily, on days 1–14 every 28 days). The starting dose of cisplatin was 60 mg/m² (level 1); the dose was escalated to 70 (level 2) and 80 mg/m² (level 3) in a stepwise fashion. Results: Fourteen patients were enrolled. The MTD of cisplatin was 80 mg/m² (level 3). DLT was grade 3 diarrhea, febrile neutropenia and delayed resumption of treatment. The RD of cisplatin was considered to be 70 mg/m² (level 2). DLT was liver dysfunction, occurring in only 1 patient at level 2. The response rate was 69.2% (9/13). Conclusions: For combined treatment with docetaxel, cisplatin and S-1 in patients with advanced gastric cancer, RD were docetaxel 40 mg/m², cisplatin 70 mg/m² and S-1 80 mg/m²/day. This regimen yields a high rate of tumor response and can be administered safely. Phase II studies of this regimen are under way.